Advanced Program in Pharmaceutical Quality Management leads to an international certification in pharmaceutical GMP compliance from NSF International and the Indian Drug Manufacturers’ Association

ANN ARBOR, Mich., YORK, UK and BANGALORE, India — NSF International, a global public health and safety organization, is again partnering with the Indian Drug Manufacturers’ Association (IDMA) to offer a customized, five-module pharmaceutical quality management (PQM) education program in Bangalore, India. Pharmaceutical industry professionals who complete the graduate-level, advanced education program will earn an internationally recognized certification in GMP compliance from NSF International and IDMA.

The Advanced Program in Pharmaceutical Quality Management consists of five modules, each lasting four days, and the program can be completed in under 10 months. A new cohort of students will participate in classes at Acharya College in Bangalore with a planned start in November 2018.

India has the highest number of GMP-approved pharmaceutical manufacturing plants outside the United States and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. According to a report by Deloitte, 64 percent of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth.

NSF International’s Advanced Program in Pharmaceutical Quality Management is taught by world-recognized leaders in PQM. The course tutors each have more than 30 years of global pharmaceutical industry experience. Several are former Medicines and Healthcare products Regulatory Agency (MHRA) inspectors and others have authored guidance documents for the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). In addition to training pharmaceutical industry professionals, NSF International has provided training to regulators from eight regulatory agencies, including agencies in the United States and the European Union (EU).

“The overwhelmingly positive reception of the first session reinforces our belief that this program addresses a pressing industry need,” said Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International.

The first cohort of more than 40 APPQM students started the NSF/IDMA program in September 2017 and completed the program by May 2018.

In his course feedback, 2017 course participant Dr. Shashikant Shinde of Mylan Labs concurred. “The course was really designed well to suit our current requirements,” said Shinde. “It will definitely help all participants make positive differences in our day-to-day work in our organizations. Thanks for the initiative and the efforts of one and all.”

“This program provides the training needed to comply with GMP requirements in Europe and the United States,” said Lush. “Together with IDMA, we’re changing how course participants think about quality and give them the knowledge and tools they need to protect their company’s legacy, reputation and future.”

The training program is designed to be highly interactive and includes modules covering best practices in PQM systems, change control and deviations, human factors in quality management, practical application of statistics, and process validation and technology transfer. The course also includes practical instruction on the leadership and communication skills required to improve business performance and regulatory compliance at pharmaceutical manufacturing operations, and to successfully interact with regulatory agencies in the United States and the EU.

Every delegate completes a project that will benefit their company; projects are agreed upon by their company sponsors, and delegates receive project coaching and consultancy support. Successfully completed projects have the potential to generate millions of dollars in savings by improving productivity and regulatory compliance.

NSF International is an independent, global organization that facilitates standards development, and tests and certifies products for the health sciences, water, food and consumer goods industries to minimise adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 175 countries, NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Centre on Food Safety, Water Quality and Indoor Environment.

NSF’s health sciences services include training and education, consulting, regulatory guidance, corporate compliance and, separately, auditing, GMP and drug packaging testing, DNA testing, certification and R&D for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.

The Indian Drug Manufacturers’ Association (IDMA) is a leading association of Indian pharmaceutical manufacturers with over 1,000 members. The objective of IDMA is to foster industry growth by focussing on patient welfare and promoting quality and business excellence in the sector. IDMA is the voice of the national sector and works in close collaboration with the government, regulatory agencies, academia and other associations for the progress of the industry.